olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide

Product NDC: 49884-787
11-digit product format: 498840787
Labeler code: 49884
Product ID: 49884-787_9ce53e8f-235a-4ebc-b1b1-4e764daacab2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Par Health USA, LLC
Application: ANDA206137
Marketing category: ANDA
Marketing start: 2016-10-26
Substance: AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Active strength: 5; 12.5; 40 mg/1; mg/1; mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	49884-787		I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	49884-787	49884-787-09	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	49884-787	49884-787-11	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A206137-001	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	2016-10-26
A206137-002	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26
A206137-003	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26
A206137-004	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26
A206137-005	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A206137-001	AB
A206137-002	AB
A206137-003	AB
A206137-004	AB
A206137-005	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206137-001	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	2016-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206137-002	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206137-003	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206137-004	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206137-005	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206137-001	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	2016-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206137-002	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206137-003	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206137-004	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206137-005	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206137-001	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	2016-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206137-002	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206137-003	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206137-004	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206137-005	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206137-001	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	2016-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206137-002	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206137-003	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206137-004	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206137-005	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206137-001	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	2016-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206137-002	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206137-003	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206137-004	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206137-005	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206137-001	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	2016-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206137-002	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206137-003	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206137-004	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206137-005	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206137-001	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	2016-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206137-002	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206137-003	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206137-004	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206137-005	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206137-001	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;20MG	TABLET / ORAL	AB	2016-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206137-002	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206137-003	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 5MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206137-004	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;12.5MG;40MG	TABLET / ORAL	AB	2016-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206137-005	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	EQ 10MG BASE;25MG;40MG	TABLET / ORAL	AB	2016-10-26	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206137-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206137-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206137-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206137-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206137-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206137-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206137-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206137-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206137-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206137-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206137-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206137-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206137-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206137-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206137-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206137-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206137-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206137-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206137-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206137-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206137-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206137-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206137-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206137-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206137-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206137-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206137-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206137-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206137-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206137-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206137-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206137-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206137-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206137-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206137-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206137-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206137-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206137-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206137-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206137-005	AB	1	`5bbf6a4d5a75…`

Additional Listing Data#

Finished product: Yes
Brand name base: olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OLMESARTAN MEDOXOMIL	5 mg/1
AMLODIPINE BESYLATE	12.5 mg/1
HYDROCHLOROTHIAZIDE	40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
864V2Q084H	Internal UNII lookup
6M97XTV3HD	Internal UNII lookup
0J48LPH2TH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
999967	Internal RxNorm lookup
999986	Internal RxNorm lookup
999991	Internal RxNorm lookup
999996	Internal RxNorm lookup
1000001	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
268d12e8-1cfc-4086-b613-8fd94f2d7c4e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fa898d56-9495-d6f0-309b-68a5d8e3914a	Product name	4	20260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
1199f4b7-b537-466c-9a1c-cb09131e9f8b	Product name	1	20251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6f	Product name	3	20251027
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
265792b3-b999-c010-7364-a7db20b9d4d9	Product name	5	20250515
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
caadbc51-b731-1a7b-b91a-f7bb4a62554e	Product name	9	20240306
14c2c15b-f823-4ada-a40e-a440544294dc	Product name	1	20221207
162cbc9d-ecc3-72ba-af9f-c76e2756ef54	Product name	3	20221207
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0ea	Product name	1	20200505
a72887ef-d675-499f-af4b-78688f6855cd	Product name	1	20191002
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
8b67f333-47d1-8464-7ce4-406d3dbb295f	Product name	7	20190618
89a57420-ab44-5323-14f9-595159145f9b	Product name	2	20190612
c27b049d-3258-48cf-ebe5-08c236ae78e2	Product name	3	20190610
a4484670-2869-6416-f6ff-03b1b3cbd1b0	Product name	2	20190415
4a27501f-a987-48a5-99b4-e983d4744d76	Product name	7	20181211
18600d07-613d-bf9c-2711-fe40c06f3393	Product name	5	20180703
00fc2cf9-672f-3e0b-6afa-43cbc864d058	Product name	4	20180613
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108
a7349398-661d-d9fc-46df-7e128bbd61d9	Product name	5	20171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719
bded1554-44de-900a-5297-403365d6d4b2	Product name	3	20170110
e0eeb018-194e-4b70-a57d-bac47a97b8ea	Product name	1	20160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1	Product name	1	20150316
ea069444-e874-4c28-833f-d2f52734ef4d	Product name	1	20150206
041df61b-f8b6-48a6-7b67-411e1412678b	Product name	1	20140508
0ad8bdca-888e-00da-648b-6a4de854a167	Product name	1	20140508
433a3439-b8f3-d13a-d2c8-9b221d628d60	Product name	1	20140508
59212689-39e5-a976-6d21-882d76d8079a	Product name	1	20140508
63ab5fbf-2a6b-c41d-051a-39e845d718b1	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
78637fb0-95c8-441f-e4b4-db1274b6f956	Product name	1	20140508
df89bd47-2db4-d593-ab37-d11953fd5536	Product name	1	20140508
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
49884-787-09	2022-09-27	These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2010
49884-787-11	2022-09-27	These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2010
49884-787-09	2022-07-29	These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2010
49884-787-11	2022-07-29	These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE TABLETS. OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 2010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49884-787-09	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	90 in 1 BOTTLE	TABLET, FILM COATED	90		23
49884-787-11	olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	30 in 1 BOTTLE	TABLET, FILM COATED	30		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-787-09	EA - Each	49884-787	ca6ab460-ddc1-4e09-beac-a6952dafd284	1	2016-11-08
49884-787-11	EA - Each	49884-787	941de24e-c965-4f04-ae6f-69760fa5c1b5	1	2016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49884-787	OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ENDO USA, INC.]	21	Current NDC, Legacy NDC, 2 package rows	20250426_268d12e8-1cfc-4086-b613-8fd94f2d7c4e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE	Par Health USA, LLC	268d12e8-1cfc-4086-b613-8fd94f2d7c4e	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206137 application number: ANDA206137 ndc (product): 49884-787
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE	REMEDYREPACK INC.	57ffeef7-bfa8-4f92-aadc-23cd00022607	2026-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206137 application number: ANDA206137
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	49ec5ac8-a626-4ab2-9799-8a138920201e	2024-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206137 application number: ANDA206137
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	204592ba-a68f-452a-9987-1b33b7b6c4d5	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206137 application number: ANDA206137
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	be69f132-8b77-4590-a688-cb3709649466	2024-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206137 application number: ANDA206137
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	a6ebafdc-4301-4d6c-b578-b3212648b13a	2024-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206137 application number: ANDA206137
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	b404a550-0df4-404a-8d10-c35e197ca399	2024-02-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206137 application number: ANDA206137
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	44dc874b-4377-46eb-ae32-8d84c9c4d4ae	2024-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206137 application number: ANDA206137
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE	Bryant Ranch Prepack	900024f4-23d6-4505-81db-4f643e12858c	2023-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206137 application number: ANDA206137

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
864V2Q084H	AMLODIPINE BESYLATE	111470-99-6	AMLODIPINE BESYLATE
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE
6M97XTV3HD	OLMESARTAN MEDOXOMIL	144689-63-4	OLMESARTAN MEDOXOMIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
999967	olmesartan medoxomil 20 MG / amLODIPine 5 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	268d12e8-1cfc-4086-b613-8fd94f2d7c4e	23
999986	olmesartan medoxomil 40 MG / amLODIPine 10 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	268d12e8-1cfc-4086-b613-8fd94f2d7c4e	23
999991	olmesartan medoxomil 40 MG / amLODIPine 10 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	268d12e8-1cfc-4086-b613-8fd94f2d7c4e	23
999996	olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	268d12e8-1cfc-4086-b613-8fd94f2d7c4e	23
1000001	olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	268d12e8-1cfc-4086-b613-8fd94f2d7c4e	23
999986	amlodipine 10 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet	SCD	268d12e8-1cfc-4086-b613-8fd94f2d7c4e	23
999991	amlodipine 10 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral Tablet	SCD	268d12e8-1cfc-4086-b613-8fd94f2d7c4e	23
999967	amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet	SCD	268d12e8-1cfc-4086-b613-8fd94f2d7c4e	23
999996	amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet	SCD	268d12e8-1cfc-4086-b613-8fd94f2d7c4e	23
1000001	amlodipine 5 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral Tablet	SCD	268d12e8-1cfc-4086-b613-8fd94f2d7c4e	23
999991	amlodipine (as amlodipine besilate) 10 MG / HCTZ 25 MG / olmesartan medoxomil 40 MG Oral Tablet	SY	268d12e8-1cfc-4086-b613-8fd94f2d7c4e	23
1000001	amlodipine (as amlodipine besilate) 5 MG / HCTZ 25 MG / olmesartan medoxomil 40 MG Oral Tablet	SY	268d12e8-1cfc-4086-b613-8fd94f2d7c4e	23
999996	amlodipine (as amlodipine besilate) 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet	SY	268d12e8-1cfc-4086-b613-8fd94f2d7c4e	23
999986	amlodipine (as amlodipine besylate) 10 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet	SY	268d12e8-1cfc-4086-b613-8fd94f2d7c4e	23
999967	amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet	SY	268d12e8-1cfc-4086-b613-8fd94f2d7c4e	23
999986	Amlodipine 10 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral Tablet	SY	268d12e8-1cfc-4086-b613-8fd94f2d7c4e	23
999991	Amlodipine 10 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral Tablet	SY	268d12e8-1cfc-4086-b613-8fd94f2d7c4e	23
999967	Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 20 MG Oral Tablet	SY	268d12e8-1cfc-4086-b613-8fd94f2d7c4e	23
999996	Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral Tablet	SY	268d12e8-1cfc-4086-b613-8fd94f2d7c4e	23
1000001	Amlodipine 5 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral Tablet	SY	268d12e8-1cfc-4086-b613-8fd94f2d7c4e	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-787-09	49884078709	90 TABLET, FILM COATED in 1 BOTTLE (49884-787-09)	2016-10-26	0000-00-00	No	No	Current
49884-787-11	49884078711	30 TABLET, FILM COATED in 1 BOTTLE (49884-787-11)	2016-10-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide	Par Health USA, LLC	2026-03-31	HUMAN PRESCRIPTION DRUG LABEL	23